BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 9496471 · Received December 19, 2019

    Report

    Report Number
    3025141-2019-00632
    Event Type
    Injury
    Date Received
    December 19, 2019
    Report Date
    December 6, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00630: CASE 1, 3025141-2019-00631: CASE 2, 3025141-2019-00633: CASE 4.

    Description of Event or Problem · 1

    ARTICLE: HYALURONIC ACID-BASED MESH ADD-ON ILIAC AUTOGRAFT IMPROVES BONE HEALING AND FUNCTIONAL OUTCOMES IN ATROPHIC NONUNION OF CLAVICULAR MIDSHAFT: A 2-YEAR FOLLOWUP; KIR, MUSTAFA CAGLAR; INDIAN J ORTHOP 2019;53:459-64. CASE 3: PATIENT'S BROKEN CLAVICLE WAS TREATED BY IMPLANTING AN ACUMED LOCKING CLAVICLE PLATE. PATIENT EXPERIENCED NONUNION AND UNDERWENT REVISION SURGERY POST OP. A NEW PLATE, ALONG WITH HA-BASED MESH AND AUTOGRAFT, WAS IMPLANTED. COMPLETE UNION WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292227 PLATE, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention